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Overview

The early access to medicines scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.

Under the scheme, the Medicines and Healthcare products Regulatory Agency (MHRA) will give a scientific opinion on the benefit/risk balance of the medicine, based on the data available when the EAMS submission was made.

The opinion lasts for a year and can be renewed.

The scheme is voluntary and the opinion from MHRA does not replace the normal licensing procedures for medicines.

The scientific opinion will be provided after a 2-step evaluation process:

the promising innovative medicine (PIM) designation

the early access to medicines scientific opinion

Promising innovative medicine (PIM) designation

The PIM designation will give an indication that a product may be eligible for the EAMS based on early clinical data. The PIM designation will be issued after an MHRA scientific meeting and could be given several years before the product is licensed. So far there have been 6 PIM designations awarded.

Scientific opinion

The scientific opinion describes the risks and benefits of the medicine based on data gathered from the patients who will benefit from the medicine.
The opinion supports the prescriber and patient to make a decision on whether to use the medicine before its licence is approved.

EAMS public assessment report (PAR)

Following a positive EAMS scientific opinion, MHRA will publish a public assessment report (PAR) and the EAMS treatment protocol on GOV.UK. The PAR will include:

how the product is used and how it works

summary of the key clinical studies

the risks and benefits of the product

the reason for the positive EAMS scientific opinion

any uncertainties

information about ongoing clinical studies

measures in place to monitor and manage risk

Dates for submission

You need to make your EAMS scientific opinion submission by 1 of the dates below:

5 January 2015

2 February 2015

2 March 2015

30 March 2015

4 May 2015

1 June 2015

29 June 2015

3 August 2015

31 August 2015

28 September 2015

26 October 2015

Periodic updates and renewals

Once you have received a positive EAMS scientific opinion you must provide MHRA with regular updates. The exact frequency of these updates will be agreed before the scientific opinion is issued but is likely to be every 3 months.